A Study of E6005 in Japanese Patients With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01179880
First received: August 4, 2010
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

The safety and pharmacokinetics of topical application with E6005 ointment compared to vehicle will be evaluated in Japanese male patients with atopic dermatitis. Additionally, the efficacy of topical application with E6005 ointment will be explored in Japanese male patients with atopic dermatitis.


Condition Intervention Phase
Atopic Dermatitis
Drug: E6005
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of E6005 in Japanese Patients With Atopic Dermatitis

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Pharmacokinetic parameter Cmax will be calculated [ Time Frame: Until Day 13 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter tmax will be calculated [ Time Frame: Until Day 13 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter AUC(0-t) will be calculated [ Time Frame: Until Day 13 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter t1/2 will be calculated [ Time Frame: Until Day 13 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E6005
Four Steps of Ointment Application: Step 1: 0.01% of E6005; Step 2: 0.03% of E6005; Step 3: 0.1% of E6005; Step 4: 0.2% of E6005.
Placebo Comparator: 2 Drug: Placebo
Matching placebo for each step

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria;

  • Japanese adult male patients with a confirmed diagnosis of atopic dermatitis according to "Guidelines for Management of Atopic Dermatitis" by the Japanese Dermatological Association.
  • Patients with evaluable typical eczema on the back (posterior trunk).
  • Patients whose age is equal to or more than 20 and less than 65 at the time of treatment and who can provide written informed consent.

Exclusion criteria;

  • Patients complicated with eye symptoms (e.g., cataract, retinal detachment), Kaposi varicelliform eruption, and molluscum contagiosum or impetigo contagiosa.
  • Patients who had or have a severe allergy such as anaphylactic shock, anaphylactic reaction and anaphylactoid reaction or allergy/hypersensitivity to E6005 or any of their excipients.
  • Patients who received any concomitant ethical drugs or any phototherapies within 14 days prior to Baseline. Subjects are allowed to use external steroids and tacrolimus ointment 8 or more days before Baseline and bland emollients free of medicinal properties (e.g., white petrolatum) throughout the study period.
  • Patients with any infection that required hospitalization or intravenous/oral treatment with antibiotic/antiviral/antifungal drug(s) within 28 days prior to Baseline.
  • Patients who had or have any malignancy, lymphoma, leukemia, or lymphoproliferative disorders, which dose not include skin cancers (e.g., squamous cell carcinoma or basal cell cancer) that were completely removed and have not metastasized for 5 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179880

Locations
Japan
Fukuoka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Fuminori Ohba Frontier Product Creation Unit, Eisai Product Creation Systems
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01179880     History of Changes
Other Study ID Numbers: E6005-J081-101
Study First Received: August 4, 2010
Last Updated: January 31, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Dermatitis
Atopic

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014